QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA— 510(k) DEN000007

Name: FDA 510(k) clearance DEN000007
Creator: U.S. Food and Drug Administration
Published: 2000-08-16

Unknown

Inova Diagnostics, Inc.

FDA 510(k) clearance DEN000007 for QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA, Unknown on 2000-08-16. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code NBT
Device class: Class 2
Regulation: 21 CFR 866.5785
Advisory panel: Immunology
Date received: 2000-07-18
Decision date: 2000-08-16
Decision: Unknown
Clearance type: Post-NSE
Location: San Diego, CA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.